Steba Biotech Completes its European Phase 3 Clinical Trial of TOOKAD®

Steba Biotech has completed the European Phase 3 clinical trial of PCM301, also known as TOOKAD® (padeliporfin di-potassium), a novel investigational treatment for localized prostate cancer and other solid tumors. PCM301 is the first prospective randomized controlled trial evaluating the efficacy and safety of a focal therapy in prostate cancer.
According to the company’s press release:

Based on these results, Steba Biotech has submitted on January 7, 2016 a Marketing Authorization Application (MAA) to the European Medicine Agency (EMA) for TOOKAD®. The MAA requests EMA approval of TOOKAD® for the treatment of localized prostate cancer.

Raphael Harari, Chief Executive Officer of Steba Biotech commented:

With the completion of the PCM301 trial, our clinical experience with TOOKAD® now includes nearly 450 patients. We look forward to having the lead study investigator, Mark Emberton, M.D., share the full data at the upcoming European Association of Urology meeting. The submission of the MAA for TOOKAD® is a major milestone for Steba Biotech and we look forward to working closely with the EMA during the review period. If approved, TOOKAD® would provide physicians and patients with a unique innovative solution to manage low-risk prostate cancer.

Click here to view the full press release.